Document Control Manager

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Cristcot

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2008

💊 Pharmaceutique

🔬 Science

💰 €10 473 043 Venture Round - Cristcot en 2025-06

Pharmaceuticals • Science

Cristcot est une entreprise de développement et de recherche pharmaceutique spécialisée dans les formulations de médicaments innovantes et les technologies combinées médicament-dispositif discrètes conçues pour améliorer l'observance des patients, réduire la charge thérapeutique et intégrer les thérapies dans la vie quotidienne. Fondée en 2008 et basée à Austin, Texas, Cristcot fournit la conception et l'exécution de recherches cliniques, l'ingénierie de formulations et de modes d'administration novateurs, le développement de dosages spécialisés, et le soutien à la stratégie réglementaire ; sa principale thérapie expérimentale a achevé une étude pivot de Phase 3. L'entreprise se concentre sur la résolution des obstacles souvent négligés dans la gestion des maladies en créant des solutions intuitives et économiques permettant des soins plus efficaces et plus sûrs.

Description

• Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates. • Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed. • Ensure proper version control, archival, retrieval, and distribution of documents • Establish and maintain document control procedures aligned with GxP requirements • Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820) • Support internal and external audits, inspections, and regulatory submissions • Maintain audit-ready documentation and ensure inspection readiness at all times • Partner with QA to enforce document control policies and best practices • Develop and implement scalable document control processes to support company growth • Identify gaps and drive continuous improvement initiatives • Lead implementation or upgrades of document management systems • Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams • Train employees on document control procedures and systems • Serve as the subject matter expert (SME) for document control across the organization • Hire, mentor, and manage document control staff as the organization grows • Establish performance metrics and ensure high-quality output

🎯 Exigences

• Bachelor’s degree in Life Sciences, Quality, or related field • 5–8+ years of experience in document control within biotech, pharma, or regulated industry • Strong knowledge of GxP requirements and regulatory standards (FDA, EMA, ISO 13485, Medical Device, and ICH) • Experience with electronic document management systems (e.g., Compliance Quest, Veeva Vault, MasterControl, Documentum) • Demonstrated ability to manage document lifecycles and ensure audit readiness • Experience in early-stage or rapidly scaling biotech companies preferred • Familiarity with clinical-stage and/or commercial manufacturing environments preferred • Experience supporting regulatory submissions (IND, NDA) preferred • Lean / Six Sigma or process improvement experience preferred • Exceptional attention to detail and organizational skills • Strong understanding of compliance and regulatory expectations • Ability to work independently in a fast-paced, evolving environment • Excellent communication and training skills • Problem-solving mindset with a focus on continuous improvement

🏖️ Avantages

• Health insurance • Professional development opportunities